Status: Closed
Activation Date: 2002AUG08
Closing Date: 2004JAN30
Phase: II
Description: A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia
Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation.
Objective: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated.
Participation: Limited to centres expecting to accrue > 4 patients/year
Lay Description: Chronic lymphocytic leukemia (CLL) is often treated with a kind of chemotherapy drug called fludarabine, which is given intravenously. Recently, this drug has become available in a pill form (taken by mouth).The purpose of this study is to find out what effects giving oral fludarabine this cancer.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| HEMATOLOGIC | CL2 | 128 | 0 | 0 | 0 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| HEMATOLOGIC | CL2 | 128 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| HEMATOLOGIC | CL2 | 128 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |